Archive for month: March, 2025

Korea: A recent retrospective cohort study published in the Journal of the American Academy of Dermatology explored the link between biologic and nonbiologic systemic therapies for psoriasis and psoriatic arthritis (PsA) and their impact on the risk of new-onset and recurrent major adverse cardiovascular events (MACE).

The US Food and Drug Administration (FDA) has granted marketing authorization for the first at-home test to diagnose chlamydia, gonorrhea, and trichomoniasis in females. The Visby Medical Women’s Sexual Health Test does not require a prescription and uses a vaginal swab for sample collection. Results are available within about 30 minutes through a secure app.

“Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health. “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.”

According to the Centers for Disease Control and Prevention’s Sexually Transmitted Infections (STI) Surveillance Report, more than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023. Additionally, it is estimated that trichomoniasis is the most prevalent nonviral STI worldwide, affecting approximately 2.6 million people in the U.S., according to the CDC’s treatment guidelines. Typically, all three infections can be treated with antibiotics, but if left untreated, can cause serious health complications for patients, including infertility.

The Visby Medical Women’s Sexual Health Test is a single use, at home test, that includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to the Visby Medical App, which displays results when the test is complete.

In individuals with and without symptoms, the Visby Medical Women’s Sexual Health Test correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples.

Individuals with positive results for any of the three infections should seek medical care. Individuals with symptoms, recent exposure to an STI or other concerns despite a negative result should contact their health care provider for additional testing.

As with many other tests, the risks associated with this test are mainly the possibility of false positive and false negative test results. False negative test results can result in delays to effective treatment and spread of infection to other persons. False positive results could lead to unnecessary treatment and/or a delay in receiving a correct diagnosis and appropriate treatment.

The FDA reviewed this test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways.

This announcement follows last year’s authorization of the first at-home syphilis test, as well as the authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV.

A recent study published in Engineering has identified a potential new approach to managing sleep disorders. The research, led by a team of scientists from Jiangnan University and other institutions, focuses on the role of S-adenosylmethionine (SAM)-producing probiotics in regulating sleep and circadian rhythms.

Insomnia is a common sleep disorder that affects a significant portion of the global population. Current first-line medications for sleep disorders often have suboptimal effectiveness, highlighting the need for novel therapeutic strategies. In this study, the researchers first conducted a cross-sectional analysis and found that serum SAM levels were significantly reduced in insomnia patients. This discovery suggests that SAM could serve as a potential biomarker and therapeutic target for sleep disorders.

The team then screened 60 gut strains and identified Lactobacillus helveticus CCFM1320, a high-SAM-producing probiotic. In a mouse model of sleep deprivation, treatment with CCFM1320 reversed neurobehavioral abnormalities, such as improved recognition and memory of new objects, reduced hyperactivity, and enhanced spatial exploration ability. Mechanistically, CCFM1320 enhanced the methylation of N-acetylserotonin, a precursor of melatonin synthesis, which normalized the expression of downstream circadian rhythm genes.

To further evaluate the clinical efficacy of CCFM1320, the researchers conducted a four-week placebo-controlled clinical trial involving 60 volunteers with insomnia. The results showed that CCFM1320 significantly improved sleep quality in patients with sleep disorders. Participants had reduced Pittsburgh sleep quality index (PSQI) scores, lower serum cortisol levels, and a decreased prevalence of pathogenic species in the gut. Additionally, probiotic treatment elevated the abundance of SAM synthesis and metabolism-related enzyme genes in the gut microbiome.

The study also explored the impact of CCFM1320 on the gut microbiota of insomnia patients. Although the overall gut microbiota diversity did not change, the intervention affected the composition and abundance of core microbiota species. Probiotic treatment reduced the number of potentially pathogenic species and increased the abundance of some beneficial bacteria.

However, the study has some limitations. The efficiency of gut microbiota-derived SAM supplementation to the circulatory system and brain requires further validation. Also, the differences in the effects of probiotics on sleep quality indices and hormone levels between the human trial and animal studies need to be further investigated.

Overall, this research presents a promising probiotic-based strategy for managing sleep disorders, offering a potential non-pharmacological treatment alternative. Further studies are needed to fully understand the mechanisms and optimize the use of these probiotics in clinical practice.

Reference:

“Regulation of Sleep and Circadian Rhythms by S-Adenosylmethionine-Producing Probiotics,” authored by Peijun Tian, Yuming Lan, Zhiying Jin, Feng Hang, Xuhua Mao, Xing Jin, Gang Wang, Wei Chen. https://doi.org/10.1016/j.eng.2024.12.025.

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